Method development and validation of clobazam in bulk and pharmaceutical dosage forms by using high performance thin layer chromatographic method

 
 
 
  • Abstract
  • Keywords
  • References
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  • Abstract


    In the present research a simple, accurate, precise and cost-effective High-performance thin layer chromatographic method for the estimation of clobazam, in bulk and pharmaceutical dosage form was illustrated. The RF value of the drug was found to be 0.74 in the mobile phase, acetone: toluene: formic acid (1: 1: 0.05 v/v/v). A linear response was observed in the range of 100-700 ng with a regression coefficient of 0.999. Validation parameters were carried out as per the guidelines of International Conference for Harmonization (ICH). This method can be used in the industries for determination of clobazam to analyze the quality of formulation without interference of the excipients.

     


  • Keywords


    Clobazam; Anti-Epileptic; λ max; ICH; High Performance Thin Layer Chromatography.

  • References


      [1] Senthilkumar, G. P., Parag, S, Mahadik., Parthiban, S., Tamizhmani, T., 2016. Method development and validation of clobazam in bulk and pharmaceutical dosage forms by using RP-HPLC Method. Am. J. Pharm Tech Res. 6, 624-31.

      [2] Jat, R. K., Sharma, R. C., 2011. Research Article Quantitative Estimation of Clobazam in Bulk drug and tablets. IJCPR. 1, 19-24.

      [3] Effat Souri., Amin Dastjani Farahani., Reza Ahmadkhaniha., Mohsen Amini., 2014. A stability indicating HPLC method for the determination of clobazam and its basic degradation product characterization. DARU Journal of pharmaceutical sciences. 22, 02-07. https://doi.org/10.1186/2008-2231-22-49.

      [4] Indian Pharmacopoeia, 5th edition, Indian Pharmacopoeia Commission, Gagiabad, India 2007(2), 945-47.

      [5] British Pharmacopoeia, 13th edition Stationary office on behalf of Medicine and Healthcare Products Regulatory agency, London, UK 2009(1), 373.

      [6] Abounassif, M. A., Kariem, E. R., Aboul-Enein, H, Y., 1987. High-performance liquid chromatographic determination of clobazam and one of its pharmaceutical formulations. Journal of pharmaceutical and biomedical analysis. 4, 431-34. https://doi.org/10.1016/0731-7085(87)80051-1.

      [7] Pok, P. R., Mauras, M., De Saint Léger, M. N., Kuhlmann, E., Charpenel-Durat, C., Navarette, C., Duval, M. L., De Meo, P., 2010. Blood concentrations of clobazam and norclobazam in a lethal case involving clobazam, meprobamate and clorazepate. Legal Medicine. 12, 300-4. https://doi.org/10.1016/j.legalmed.2010.08.002.

      [8] Peña, M, I., Lope, E, S., 1988. Monitoring serum clobazam by isothermal gas—liquid chromatography with nitrogen detector. Journal of pharmaceutical and biomedical analysis. 6, 995-8. https://doi.org/10.1016/0731-7085(88)80122-5.

      [9] Gharge, D., Salve, P., Raut, C., Seervi, C., Pawar, K., Dhabale, P., 2010. Validated Spectroscopic Method for Estimation of Aceclofenac from Tablet Formulation. Tablet. 1(100mg), 100-2.

      [10] International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use: Harmonized Triplicate Guideline on Validation of analytical Procedures: Methodology, Recommended for Adoption at Step 4 of the ICH Process on November 1996 by ICH Steering Committee, IFPMA, Switzerland.


 

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Article ID: 30498
 
DOI: 10.14419/ijac.v8i1.30498




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